Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer’s Disease (SESAD)
Check Eligibility
The purpose of this research study is to learn more about the safety and effectiveness of a drug called sargramostim for improving cognitive function and memory in people with Alzheimer’s disease. Sargramostim is an investigational drug, meaning it has not been approved by the FDA to treat Alzheimer’s. This research study hopes to find out more about how sargramostim works within the body over a longer time period than previously studied.
Participants will be asked to participate in weekly visits for 24 weeks (6 months), as well as screening and follow-up visits. If determined to be eligible during screening, you will be assigned to one of two arms of the study: 1) receives study medication; 2) receives placebo (a pill or a liquid that looks like medicine but is not real)
These visits may include some of the following procedures:
- Cognitive testing
- Twice weekly blood draws
- Heart Tracing (ECG)
- Health Questionnaires
- Study Partner Questionnaires
- MRI
- PET scan
- Treatment/placebo injection 5x a week during treatment phase
Health insurance is not needed for this study.
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In order to qualify you must:
• be between 60-85 years old
• have a diagnosis of mild-to-moderate Alzheimer’s disease (AD)
• Not have a first degree relative diagnosed with AD before 55 years of age
• Be willing and able to have an MRI
• have a study partner willing to give daily injections after training
• be between 60-85 years old
• have a diagnosis of mild-to-moderate Alzheimer’s disease (AD)
• Not have a first degree relative diagnosed with AD before 55 years of age
• Be willing and able to have an MRI
• have a study partner willing to give daily injections after training
Duration of Participation: Potential study participants will need to initially come to CU Anschutz Medical Campus in Aurora several times for screening visits. After initial screenings at the CU Anschutz campus in
Aurora, CO, participants will be able to have weekly home nursing visits to
provide supplies and draw blood. Occasional visits to campus during the study will be required for procedures that cannot be done at home. Including screening and follow-up, study participation last up to 9-1/2 months with up to 55 visits.
Participants will receive: Study related care and medication at no cost. Compensation Provided.
To learn more, please contact us at 303-724-4644 or NeuroResearch@cuanschutz.edu or fill out the research inquiry form at www.cumemoryresearch.org